A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Tilrekimig

Study type: Interventional

Funder types: Industry

Identifiers

NCT07765888

C4531007

2026-526155-65-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body when used together with medicated creams or ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated.

• This study is seeking participants who: Are aged 12 years or older.
• Were confirmed to have atopic dermatitis (AD) at least 12 months ago.
• Are not having an effective treatment result from medicines that are applied on skin for AD.
• Are considered by their doctors to have moderate to severe AD.

Participants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20.

Some participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last study treatment dose.

Enrollment: 375 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants 12 years of age or older

• Must meet the following AD criteria:

  1. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1
  2. An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines
  3. Moderate-to-severe eczema for at least 1 year

• Adolescent participants must be up to date on immunizations per local guidance.

Exclusion criteria

• Clinically Significant Autoimmune Disease
• Significant Infection History or Active Infection
• Known or Suspected Immunodeficiency/Immunosuppression
• Significant psychiatric illness or suicidality
• Clinically significant hepatic, renal, or hematologic abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 2 patient groups, including a placebo group

Tilrekimig

Experimental group

Description:

Subcutaneous injections given over 20 weeks

Treatment:

Drug: Tilrekimig

Placebo

Placebo Comparator group

Description:

Subcutaneous injections given over 20 weeks

Treatment:

Drug: Placebo